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STATE OF MICHIGAN
DEPARTMENT OF INSURANCE AND FINANCIAL SERVICES
Before the Director of Insurance and Financial Services
In the matter of:
Petitioner
v
File No. 145791-001
Blue Cross Blue Shield of Michigan
Respondent
Issued and entered
this [pHlay ofFebruary 2015
by Randall S. Gregg
Special Deputy Director
ORDER
I. Procedural Background
On January 13, 2015,
(Petitioner) filed a request with the Director of
Insurance and Financial Services for an external review under the Patient's Right to Independent
Review Act, MCL 550,1901 et seq. After a preliminary review of the material submitted, the
Director accepted the request on January 21, 2015.
The Petitioner receives prescription drug benefits through a group plan underwritten by
Blue Cross Blue Shield of Michigan (BCBSM). The prescription drug benefits are defined in
BCBSM's Preferred RXProgram Certificate SG and its Custom Select Drug List. The Director
notified BCBSM of the external review request and asked for the information it used to make its
final adverse determination. BCBSM provided its response on January 28, 2015.
To address the medical issues in the case, the Director assigned it to an independent
medical review organization which provided its analysis and recommendation on February 4,
2015.
II. Factual Background
The Petitioner has a history of AttentionDeficit Disorder with hyperactivity (ADHD) for
which he has been taking brand name Adderall XR. In the past, BCBSM had approved coverage
for the drug in its brand name form. In December 2014, the Petitioner's physicianrequested
authorization for continued coverage of the brand name drug. BCBSM denied the request.
File No. 145791-001
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The Petitioner appealed the denial through BCBSM's internal grievance process. At the
conclusion of that process BCBSM affirmed its denial in a final adverse determination dated
December 25, 2014. The Petitioner now seeks a review of that adverse determination from the
Director.
III. Issue
Did BCBSM correctly deny preauthorization and coverage for the prescription drug
Adderall XR?
IV. Analysis
Petitioner's Argument
The Petitioner stated in his request for an external review:
I have tried taking the generic version of Adderal XR twice and each time I've
found it to cause severe side effects such as psychotic mood swings. I've been
taking the brand version of Adderal XR successfully for many, many years (10+)
and have found that to work the best out of all the meds I've tried. In December
2014 BCBSM started to deny the brand coverage and won't cover it since there is
a generic version of the drug. My Dr. has provided documentation supporting
my claims to no avail. BCBSM isn't understanding that the generic is bad for
me.
In a letter to BCBSM dated December 17, 2014, the Petitioner's physician explained the
reasons for requesting coverage of brand name Adderall XR:
The patient has history of Attention-deficit Disorder, which was controlled at one
time with generic Adderall. Overtime however, the patient became intolerant to
the generic and thus required an adjustment to brand name medication. Their
symptoms overall have been stabile since this adjustment.
Given the patients' history with generic medication, it would be medically
necessary to continue him on brand name Adderal XR.
BCBSM's Argument
In its final adverse determination, BCBSM wrote:
Your prescription drug benefits are provided under the Preferred RXProgram
Certificate and your group uses the Custom Select Drug List. Because there is a
generic version of Adderall available, brand-name Adderall is excluded from
coverage underthe Custom Select DrugList. Section 3: Prescription Drugs Not
File No. 145791-001
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Covered in the Certificate states that anything other than covered drugs and
services are not a benefit of the coverage. Thus, brand-name Adderall is not a
benefit under your plan.
*
*
*
Covered stimulant alternatives include: generic methylphenidate products
(options include Concerta, Metadate, Methylin, Ritalin). Covered non-stimulant
alternatives include: generic Kapvay (clonidine ER), and Strattera. Please refer to
your custom select drug list for a complete list of covered alternatives....
Director's Review
BCBSM's Preferred RX Program Certificate SG (page 17) provides that BCBSM will
not pay for brand-name drugs that have a generic equivalent available. BCBSM denied coverage
for Adderall XR because there are covered generic equivalents available to treat the Petitioner's
condition. However, Michigan law (MCL 500.3406o) requires health insurers providing
prescription drug coverage to make an exception to a formulary limitation when a nonformulary
alternative is medically necessary and appropriate:
An insurer that delivers, issues for delivery, or renews in this state an expenseincurred hospital, medical, or surgical policy or certificate that provides coverage
for prescription drugs and limits those benefits to drugs included in a formulary
shall do all of the following:
(c) Provide for exceptions from the formulary limitation when a nonformulary
alternative is a medically necessary and appropriate alternative. This subdivision
does not prevent an insurer from establishing prior authorization requirements or
another process for consideration of coverage or higher cost-sharing for
nonformulary alternatives....
The question of whether brand name Adderall XR is a medically necessary and
appropriate alternative for treatment of the Petitioner's condition was presented to an
independent review organization (IRO) as required by section 11(6) of the Patient's Right to
Independent Review Act, MCL 550.1911(6).
The IRO reviewer is a physician in active clinical practice who is certified by the
American Board of Family Medicine and is a senior staff physician at an east coast metropolitan
hospital. The reviewer's report included the following analysis and recommendation:
ADHD is a psychiatric disorder of the neurodevelopmental type. Symptoms are
varied and are dependent on the age of the individual and the subtypes present in
the individual. Usually, there are problems with inattentiveness, hyperactivity or
impulsiveness that is not appropriate for the person's age. In adults, ADHD
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symptoms may present differently than in children. Symptoms of an inability to
relax or the ability to talk excessively in social situations can be present;
impulsiveness in relationships and sensation seeking behaviors are often
common. Addictive behaviors involving substance abuse or gambling are also
common. It is estimated that between 2-5% of adults have ADHD; however,
most adults remain untreated. The standard of care for the treatment of ADHD
involves a combination of counseling and the use of stimulants and/or nonstimulant medications. Stimulant medications are the treatment of choice; these
include dextroamphetamine, dextroamphetamine/amphetamine, methylphenidate,
dexmethylphenldate, and lisdexamfetamine; along with their various brand name
counterparts including Adderall, Concerta, Ritalin, Focalin, Vyvanse, and
Procentra. The exact mechanism of action of the stimulant medications is
unknown but it does stimulate central nervous system (CNS) activity by blocking
the reuptake of norepinephrine and increasing the release of the norepinephrine
and dopamine in to the extra neuronal space. There are a number of nonstimulant medications that may be used as alternatives; these include atomoxetine
(Strattera), bupropion (Wellbutrin), guanfacine (Tenex, Intuniv), and clonidine
(Catapress, Kapvay). The exact mechanism of action in the treatment of ADHD
with these medications is unknown but can involve inhibiting norepinephrine
reuptake, to stimulating alpha 2 adrenergic receptors. Studies do not exist that
compare the two groups of medications, but they appear to be equal in regards to
their side effects. In this case, the enrollee was treated with a stimulant
medication of Adderall XR, the generic form being that of
dextroamphetamine/amphetamine. Adderall is a mixture of various salts, 75%
dextroamphetamine and 25% levoamphetamine. The extended release form is
designed to provide a more consistent therapeutic effect than taking two (2) doses
of the nonextended release brand or generic forms four (4) hours apart.
The brand name of Adderall XR was not medically necessary for the enrollee's
condition as it was not the only medication available for treatment of the
enrollee's condition. The enrollee states that he was tried on the generic brand
twice and was subsequently switched to the brand name. The documentation
submitted for review does not indicate any medication trials that are covered
under the Custom Select Drug List that were attempted which may have the same
therapeutic affect without the untoward side effects. There is no evidence to
support that Adderall is the only medication choice available to treat the
enrollee's condition.
The Michigan Insurance Code Section 3406o [requires] exceptions from [an
insurer's] formulary limitations when a non-formulary alternative is medically
necessary. The enrollee does not meet the criteria as Adderall does have a
generic alternative, despite the fact that the enrollee experienced an untoward
side effect from one of the generic brands. There is not any documentation
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submitted for review that the patient exhausted other covered medications,
generic or brand name if a generic was not available. Therefore, the requested
brand name prescription medication Adderall XR is not medically necessary.
[References omitted.]
The Director is not required to accept the IRO's recommendation. Ross v Blue Care
Network ofMichigan, 480 Mich 153 (2008). However, the IRO's recommendation is afforded
deference by the Director. In a decision to uphold or reverse an adverse determination the
Director must cite "the principal reason or reasons why the [Director] did not follow the assigned
independent review organization's recommendation." MCL 550.191 l(16)(b). The IRO's
analysis is based on extensive experience, expertise, and professional judgment. In addition, the
IRO recommendation is not contrary to any provision of the Petitioner's certificate of coverage.
MCL 550.1911(15). The Director can discern no reason why the IRO's recommendation should
be rejected in the present case.
Based on the IRO analysis and the absence of evidence that the Petitioner has fully
explored the efficacy of other similar, generic, covered drugs, the Director finds that Adderall
XR is not, at present, a drug for which BCBSM must provide coverage.
V. Order
The Director upholds BCBSM's final adverse determination of December 25, 2014.
BCBSM is not required to provide prescription drug coverage for brand name Adderall XR.
This is a final decision of an administrative agency. Under MCL 550.1915, any person
aggrieved by this order may seek judicial review no later than 60 days from the date of this order
in the circuit court for the Michigan county where the covered person resides or in the circuit
court of Ingham County. A copy of the petition for judicial review should be sent to the
Department of Insurance and Financial Services, Office of General Counsel, Post Office Box
30220, Lansing, MI 48909-7720.
Annette E. Flood
Director
Randall
Special Deputy Director